The present invention is directed to an improved device for performing an agglutination reaction of immunochemical particles. The agglutination reaction device is designed to provide a convenient means for performing and reading the results of an agglutination reaction. A particular improvement involves varying the geometry, namely the width and/or depth, of a portion of the path along which liquid in the device flows by capillary action.
Agglutination reactions and their procedures are generally well known in the art. A typical agglutination reaction consists of the clumping together (or aggregation) in suspension of antigen- or antibody-bearing cells, microorganisms, or particles in the presence of specific analytes. This clumping or agglutination of particles is then monitored to determine the absence or presence of an analyte sought to be detected.
One method for reacting immunochemical particle reagents involves placing liquid reagents on a glass slide and generally rocking or swirling the slide back and forth to cause the reagents to mix and form agglutinations. Methods have also been developed to avoid the necessary swirling of the particle reagents in order to visualize the agglutinations. For example, U.S. Pat. No. 4,596,695 discloses an agglutination reaction chamber for reacting immunochemical particle reagents. The chamber includes a first transparent panel having a first surface and a second panel having a second surface spaced apart from the first surface to define a chamber inbetween. The chamber intrinsically causes immunochemical particle reagents to flow by capillary action without an external motion imparted to the chamber during which flow the immunochemical particle reagents can react.
An object of the present invention is to provide a device that can be easily adapted for use in the automated diagnosis of a plurality of samples. Another object of the present invention is to provide a device capable of performing multiple, highly sensitive, diagnostic tests simultaneously on a single sample in a single device. In one aspect, the present invention is directed to a device in which the agglutination reaction can be rapidly performed and monitored with a minimum of sample material. In another aspect, the present invention is directed to a device having multiple channels radiating from a central well where multiple reactions on a single sample can be rapidly performed and monitored with a minimum of sample material with the results of such reactions being easily, visibly observable. In another aspect, the present invention is directed to devices for performing agglutination reactions having enhanced performance properties through utilization of a means for controlling the flow of liquid through the reaction chamber of the performance properties through utilization of a means for controlling the flow of liquid through the reaction chamber of the device, namely, through modification of the geometric configuration of the agglutination reaction chamber or the internal shape of the chamber so as to provide a non-random patterned array of aggregated agglutinates which non-random pattern is more easily observable than agglutinates aggregated in a random array.